While electronic health record data integration is common in clinical trials, the fragmentation of health data across sources poses challenges for its comprehensive utility in drug development. Linking real-world data (RWD) sources to trial data through privacy-preserving tokenization helps fill evidence gaps, extends follow-up beyond trials, and enables better understanding of treatment effects in diverse populations.
Study Overview
This article examines how linking clinical trial data with RWD can enhance drug development and healthcare decision-making. The authors detail how advances in computing and data analytics have enabled novel trial designs that integrate RWD with traditional clinical trial data, helping to overcome the challenge of fragmented patient health data across different sources. They explain how this linkage can be used to fill gaps in medication use data, extend observation periods beyond trial completion, validate real-world outcomes against trial standards, and better understand treatment effects in diverse populations.
The article also provides detailed guidance on the operational aspects of implementing trial-RWD linkage, including the selection of privacy-preserving record linking systems (PPRLS), development of consent processes, and management of personally identifiable information. Emphasizing the importance of carefully evaluating data quality and completeness when selecting RWD sources, the authors discuss how tokenization can be used to maintain patient privacy while enabling data linkage. They also highlight several future opportunities for linked RWD, such as improving trial recruitment through targeted patient identification and using secure computing techniques to combine RWD with consumer information for better patient outreach.
Read the full article here.